Nutritional Intake and Gut Microbiome

Nutritional Intake, Metabolic Abnormalities and Gut Microbiome in Children

Pediatric obesity has been increasing in prevalence, but concerns have been raised around the world because no treatment has been found. Recently, however, research on gut microbiome has begun to become a new alternative. It has been shown that changes in the microbiome in adults may induce obesity. However, the results on children are still scarce. Unlike adults, children have few external factors such as alcohol, tobacco, stress, and cancer, making them suitable for obesity-related gut microbiome studies. The investigators will use Illumina MiSeq platform for 16s rRNA metagenomics profiling in children. In this study, the investigators aimed to analyze the relationship between pediatric obesity, gut microbiome profile, blood biomarkers relevant to metabolic syndrome, and nutrient intake data.

Study Overview

• Status: Completed
• Conditions: Obesity, Childhood
• Intervention / Treatment: Diagnostic test: Gut microbiome profiling

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 07440
    • Hallym University Kangnam Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic and community samples

Description

Inclusion Criteria:

• Obese children: Children ≥95 ‰ between age 7 and 12 years
• Non-obese children: 5‰<BMI <85 ‰ for children between the ages of 7 and 12 years

Exclusion Criteria:

• Taking antibiotics, probiotics, or steroids for a month before visit
• Taking probiotics-like products including yogurt for seven days before visit
• Having enteritis symptoms including diarrhea for a month before visit
• Chronic heart disease, chronic bowel disease, chronic liver disease, chronic kidney disease, endocrine disease, genetic diseases or congenital metabolic disorder

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Obese children; Children ≥95 ‰ between age 7 and 12 years	Diagnostic test: Gut microbiome profiling; Gut microbial profiling will be done with next-generation sequencing targeting bacterial 16s rRNA genes.; Other Names: 16s metagenomic analysis
Non-obese children; 5‰< BMI <85 ‰ for children between the ages of 7 and 12 years	Diagnostic test: Gut microbiome profiling; Gut microbial profiling will be done with next-generation sequencing targeting bacterial 16s rRNA genes.; Other Names: 16s metagenomic analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of fecal microbial profile with childhood obesity	Analysis of fecal microbial profile using 16s rRNA sequencing	visit 1day
Correlation of fecal microbial profile with nutrient intake data using feeding diary	Nutritional intake analysis of total calorie, carbohydrate, fiber, fat, and protein from feeding dairy for two days	visit 1day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of childhood obesity with metabolic abnomalities using blood sampling	Glucose, AST, ALT, uric acid, triglyceride, HDL-cholesterol, LDL-cholesterol, total cholesterol, insulin, hsCRP, 25(OH)-Vitamin D3, hemoglobin, ferritin, and HbA1c	visit 1day

Collaborators and Investigators

• Sponsor: Hallym University Kangnam Sacred Heart Hospital
• Investigators: Principal Investigator: Ky Young Cho, M.D., Kangnam Sacred Heart Hospital, Hallym University College of Medicine

Publications and helpful links

General Publications

• David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11.
• Eckburg PB, Bik EM, Bernstein CN, Purdom E, Dethlefsen L, Sargent M, Gill SR, Nelson KE, Relman DA. Diversity of the human intestinal microbial flora. Science. 2005 Jun 10;308(5728):1635-8. doi: 10.1126/science.1110591. Epub 2005 Apr 14.
• Fadrosh DW, Ma B, Gajer P, Sengamalay N, Ott S, Brotman RM, Ravel J. An improved dual-indexing approach for multiplexed 16S rRNA gene sequencing on the Illumina MiSeq platform. Microbiome. 2014 Feb 24;2(1):6. doi: 10.1186/2049-2618-2-6.
• Schwiertz A, Taras D, Schafer K, Beijer S, Bos NA, Donus C, Hardt PD. Microbiota and SCFA in lean and overweight healthy subjects. Obesity (Silver Spring). 2010 Jan;18(1):190-5. doi: 10.1038/oby.2009.167. Epub 2009 Jun 4.
• Qin J, Li R, Raes J, Arumugam M, Burgdorf KS, Manichanh C, Nielsen T, Pons N, Levenez F, Yamada T, Mende DR, Li J, Xu J, Li S, Li D, Cao J, Wang B, Liang H, Zheng H, Xie Y, Tap J, Lepage P, Bertalan M, Batto JM, Hansen T, Le Paslier D, Linneberg A, Nielsen HB, Pelletier E, Renault P, Sicheritz-Ponten T, Turner K, Zhu H, Yu C, Li S, Jian M, Zhou Y, Li Y, Zhang X, Li S, Qin N, Yang H, Wang J, Brunak S, Dore J, Guarner F, Kristiansen K, Pedersen O, Parkhill J, Weissenbach J; MetaHIT Consortium; Bork P, Ehrlich SD, Wang J. A human gut microbial gene catalogue established by metagenomic sequencing. Nature. 2010 Mar 4;464(7285):59-65. doi: 10.1038/nature08821.
• Pedersen HK, Gudmundsdottir V, Nielsen HB, Hyotylainen T, Nielsen T, Jensen BA, Forslund K, Hildebrand F, Prifti E, Falony G, Le Chatelier E, Levenez F, Dore J, Mattila I, Plichta DR, Poho P, Hellgren LI, Arumugam M, Sunagawa S, Vieira-Silva S, Jorgensen T, Holm JB, Trost K; MetaHIT Consortium; Kristiansen K, Brix S, Raes J, Wang J, Hansen T, Bork P, Brunak S, Oresic M, Ehrlich SD, Pedersen O. Human gut microbes impact host serum metabolome and insulin sensitivity. Nature. 2016 Jul 21;535(7612):376-81. doi: 10.1038/nature18646. Epub 2016 Jul 13.
• Clemente JC, Ursell LK, Parfrey LW, Knight R. The impact of the gut microbiota on human health: an integrative view. Cell. 2012 Mar 16;148(6):1258-70. doi: 10.1016/j.cell.2012.01.035.
• Yun Y, Kim HN, Kim SE, Heo SG, Chang Y, Ryu S, Shin H, Kim HL. Comparative analysis of gut microbiota associated with body mass index in a large Korean cohort. BMC Microbiol. 2017 Jul 4;17(1):151. doi: 10.1186/s12866-017-1052-0.
• Hu HJ, Park SG, Jang HB, Choi MK, Park KH, Kang JH, Park SI, Lee HJ, Cho SH. Obesity Alters the Microbial Community Profile in Korean Adolescents. PLoS One. 2015 Jul 31;10(7):e0134333. doi: 10.1371/journal.pone.0134333. eCollection 2015. Erratum In: PLoS One. 2015;10(9):e0138015. Choi, Min-Gyu [corrected to Choi, Min-Kyu].
• Cox AJ, West NP, Cripps AW. Obesity, inflammation, and the gut microbiota. Lancet Diabetes Endocrinol. 2015 Mar;3(3):207-15. doi: 10.1016/S2213-8587(14)70134-2. Epub 2014 Jul 22.
• Turnbaugh PJ, Backhed F, Fulton L, Gordon JI. Diet-induced obesity is linked to marked but reversible alterations in the mouse distal gut microbiome. Cell Host Microbe. 2008 Apr 17;3(4):213-23. doi: 10.1016/j.chom.2008.02.015.
• Jumpertz R, Le DS, Turnbaugh PJ, Trinidad C, Bogardus C, Gordon JI, Krakoff J. Energy-balance studies reveal associations between gut microbes, caloric load, and nutrient absorption in humans. Am J Clin Nutr. 2011 Jul;94(1):58-65. doi: 10.3945/ajcn.110.010132. Epub 2011 May 4.
• Yoo JY, Kim SS. Probiotics and Prebiotics: Present Status and Future Perspectives on Metabolic Disorders. Nutrients. 2016 Mar 18;8(3):173. doi: 10.3390/nu8030173.

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2017
• Primary Completion (Actual): October 12, 2018
• Study Completion (Actual): October 12, 2018

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: December 24, 2017
• First Posted (Actual): January 3, 2018

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Microbiome; Gut
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: Gut microbiome

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study participants will only agree if IPD is not shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No